Early Diagnosis of HIV Infection in Infants — One Caribbean and Six Sub-Saharan African Countries, 2011–2015

Pediatric human immunodeficiency virus (HIV) infection remains an important public health issue in resource-limited settings. In 2015, 1.4 million children aged <15 years were estimated to be living with HIV (including 170,000 infants born in 2015), with the vast majority living in sub-Saharan Africa (1). In 2014, 150,000 children died from HIV-related causes worldwide (2). Access to timely HIV diagnosis and treatment for HIV-infected infants reduces HIV-associated mortality, which is approximately 50% by age 2 years without treatment (3). Since 2011, the annual number of HIV-infected children has declined by 50%. Despite this gain, in 2014, only 42% of HIV-exposed infants received a diagnostic test for HIV (2), and in 2015, only 51% of children living with HIV received antiretroviral therapy (1). Access to services for early infant diagnosis of HIV (which includes access to testing for HIV-exposed infants and clinical diagnosis of HIV-infected infants) is critical for reducing HIV-associated mortality in children aged <15 years. Using data collected from seven countries supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), progress in the provision of HIV testing services for early infant diagnosis was assessed. During 2011–2015, the total number of HIV diagnostic tests performed among HIV-exposed infants within 6 weeks after birth (tests for early infant diagnosis of HIV), as recommended by the World Health Organization (WHO) increased in all seven countries (Cote d’Ivoire, the Democratic Republic of the Congo, Haiti, Malawi, South Africa, Uganda, and Zambia); however, in 2015, the rate of testing for early infant diagnosis among HIV-exposed infants was <50% in five countries. HIV positivity among those tested declined in all seven countries, with three countries (Cote d’Ivoire, the Democratic Republic of the Congo, and Uganda) reporting >50% decline. The most common challenges for access to testing for early infant diagnosis included difficulties in specimen transport, long turnaround time between specimen collection and receipt of results, and limitations in supply chain management. Further reductions in HIV mortality in children can be achieved through continued expansion and improvement of services for early infant diagnosis in PEPFAR-supported countries, including initiatives targeted to reach HIV-exposed infants, ensure access to programs for early infant diagnosis of HIV, and facilitate prompt linkage to treatment for children diagnosed with HIV infection.

WHO currently recommends testing of HIV-exposed infants in resource-limited settings using polymerase chain reaction (PCR) technology at age 4–6 weeks to optimize detection of intrauterine, intrapartum, and early postnatal HIV transmissions (4). Data collected during 2011–2015 from one Caribbean and six sub-Saharan African countries supported by PEPFAR (Haiti and Cote d’Ivoire, the Democratic Republic of the Congo, Malawi, Uganda, South Africa, and Zambia) were analyzed to assess progress in the provision of services for early infant HIV diagnosis and adherence to the WHO recommendation.

CDC laboratory advisors from participating countries used a standardized questionnaire to abstract laboratory and clinical data from national laboratory databases on number of infant HIV tests, percent HIV positive, age of infant at time of test, turnaround time from specimen collection to return of laboratory results to health facility, and mode of specimen transportation. In addition, information was collected from laboratory databases on the number of sites collecting dried blood spots (because of simplified collection, transport, and storage, this is the type of specimen collected in resource-constrained settings for early diagnosis of HIV among infants); the number of laboratories providing services for early infant diagnosis; and the number of laboratories enrolled in proficiency testing programs. Laboratory managers reported operational challenges to and successes of testing for early infant diagnosis by responding to open-ended questions.

During 2011–2015, the total number of HIV diagnostic tests performed for infants increased in all seven countries, with the highest increase reported by Uganda (513%) and the lowest by Zambia (6%) in 2015 (Table 1). The rate of early infant testing performed within 6 weeks of birth among HIV-exposed infants was low to moderate, varying from 15% in the Democratic Republic of the Congo to 62% in South Africa in 2015. During 2011–2015, an upward trend in testing for early infant diagnosis was observed in Cote d’Ivoire and Zambia, and a stable trend was observed in Haiti, Malawi, and South Africa. Uganda and the Democratic Republic of the Congo had a sharp drop in the number of early HIV tests performed for infants, with the largest decrease observed from 2014 to 2015 (Table 1). During 2011–2015, the infant HIV positivity rate declined in all seven countries, with three countries reporting >50% decline. Uganda reported the largest (60%) relative decrease, a decline from 10% in 2011 to 4% in 2015; Haiti reported the lowest (25%) relative decrease, a decline from 8% in 2012 to 6% in 2015.

During 2011–2015, the number of dried-blood-spot collection sites increased in all countries except in South Africa and Malawi, where the numbers of sites were stable. In 2015, South Africa had the highest number of dried-blood-spot collection sites (n = 3,500); although Haiti had the lowest number (n = 129) of collection sites in 2015, the number represented a 146% increase in sites compared with 2011. Three countries reported more laboratories using PCR to detect HIV infection among infants: Cote d’Ivoire, the Democratic Republic of the Congo, and Malawi. In all seven countries, all laboratories performing early infant testing for HIV participated in a proficiency-testing program, and all laboratories had a proficiency testing score ≥95% during the 5 years.

During 2011–2015, the mean testing turnaround time, from blood collection to results returned to the referring health facility, was documented in five countries. The shortest mean turnaround time was 22 days in Haiti in 2012 and the longest was 60 days in Uganda in 2012 and 2013. By 2015, only Cote d’Ivoire and Uganda saw improvements, with 50% declines in turnaround time (Table 2). Specimens were transported from the referring health facility to the testing laboratory by bicycle, motorcycle, or car. Various approaches were used for transmitting test results back to the referring facility: phone, text messages, email, hard copies transported by vehicle, and web-based laboratory–information-system searches.

The most common reported challenges in access to services for early infant diagnosis included weak sample referral networks, long turnaround time, and limitations in supply chain management (Table 3). Three countries reported that integration of services for early infant diagnosis with other programs, including those providing immunizations, pediatric care, and health outreach in the community, were integral to success of access to testing for early infant diagnosis. Use of dried blood spots (Malawi and South Africa) and improvement in specimen referral networks (Malawi and Uganda) also were important factors for increasing access to early testing. Challenges to implementation of testing for early infant diagnosis included mother and child being lost to follow-up, weak linkage between programs, (i.e., programs for the prevention of mother-to-child transmission and care/antiretroviral therapy), and inability to reach infants outside of the health care system.

Corresponding author: Karidia Diallo, kdiallo@cdc.gov, 404-639-3568.

¹Center for Global Health, Division of Global HIV and TB, CDC; ²Center for Global Health, Division of Global HIV and TB, CDC, Kinshasa, Democratic Republic of the Congo (DRC); ³Laboratoire National de Référence du SIDA, Kinshasa, DRC; ⁴Programme National de Lutte contre le SIDA, Kinshasa, Democratic Republic of the Congo; ⁵Center for Global Health, Division of Global HIV and TB, CDC, Kampala, Uganda; ⁶Central Public Health Laboratories, Kampala, Uganda; ⁷Center for Global Health, Division of Global HIV and TB, CDC, Port-au-Prince, Haiti; ⁸United States Agency for International Development, Port-au-Prince, Haiti; ⁹Laboratoire National de Santé Public, Port-au-Prince, Haiti; ¹⁰Programme National de Lutte contre le SIDA, Port-au-Prince, Haiti; ¹¹Group Haïtien d’Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-Au-Prince, Haiti; ¹²CARIS Foundation, Port-au-Prince, Haiti; ¹³Center for Global Health, Division of Global HIV and TB, CDC, Lilongwe, Malawi; ¹⁴Ministry of Health, Lilongwe Malawi; ¹⁵Center for Global Health, Division of Global HIV and TB, CDC, Pretoria, South Africa; ¹⁶Department of Haematology and Molecular Medicine, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa; ¹⁷Health Economics and Epidemiology Research Office, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; ¹⁸Department of Paediatrics and Child Heath, University of the Witwatersrand, Johannesburg, South Africa; ¹⁹Center for HIV and STI, National Institute for Communicable Diseases, Johannesburg, South Africa; ²⁰National Department of Health, Pretoria, South Africa; ²¹Center for Global Health, Division of Global HIV and TB, CDC, Lusaka, Zambia; ²²Ministry of Health, Lusaka, Zambia; ²³Association of Public Health Laboratories, Lusaka, Zambia; ²⁴Center for Global Health, Division of Global HIV and TB, CDC, Abidjan, Cote d’Ivoire; ²⁵Programme National de Lutte contre le SIDA, Abidjan, Cote d’Ivoire.

References

1. Joint United Nations Programme on HIV/AIDS (UNAIDS). On the fast-track to an AIDS-free generation: the incredible journey of the global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive. Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS (UNAIDS); 2016. http://www.unaids.org/sites/default/files/media_asset/GlobalPlan2016_en.pdf
2. Joint United Nations Programme on HIV/AIDS (UNAIDS). How AIDS changed everything. MDG 6: 15 years, 15 lessons of hope from the AIDS response. Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS (UNAIDS); 2015. http://www.unaids.org/sites/default/files/media_asset/MDG6Report_en.pdf
3. Violari A, Cotton MF, Gibb DM, et al. ; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med 2008;359:2233–44. CrossRef PubMed
4. World Health Organization. Recommendations on the diagnosis of HIV infection in infants and children. Geneva, Switzerland: World Health Organization; 2010. http://whqlibdoc.who.int/publications/2010/9789241599085_eng.pdf?ua=1
5. Kebede Y, Fonjungo PN, Tibesso G, et al. Improved specimen-referral system and increased access to quality laboratory services in Ethiopia: the role of the public-private partnership. J Infect Dis 2016;213(Suppl 2):S59–64. CrossRef PubMed
6. Phelps BR, Ahmed S, Amzel A, et al. ; Child Survival Working Group of the Interagency Task Team on the Prevention, Treatment of HIV infection in Pregnant Women, Mothers, Child. Linkage, initiation and retention of children in the antiretroviral therapy cascade. AIDS 2013;27(Suppl 2):S207–13. CrossRef PubMed
7. Garcia A, Subbarao S, Zhang G, et al. Impact of proficiency testing program for laboratories conducting early diagnosis of HIV-1 infection in infants in low- to middle-income countries. J Clin Microbiol 2014;52:773–80. CrossRef PubMed
8. Stevens W, Sherman G, Downing R, et al. Role of the laboratory in ensuring global access to ARV treatment for HIV-infected children: consensus statement on the performance of laboratory assays for early infant diagnosis. Open AIDS J 2008;2:17–25. CrossRef PubMed
9. Nkengasong JN, Parekh BS, Hader SL. HIV testing and human rights: the right to the right test. Lancet HIV 2016;3:e457–8. CrossRef PubMed
10. World Health Organizaiton. WHO validates countries’ elimination of mother-to-child transmission of HIV and syphilis. Geneva, Switzerland: World Health Organization; 2016. http://www.who.int/mediacentre/news/statements/2016/mother-child-hiv-syphilis/en/

TABLE 1. Number of infant HIV tests, proportion meeting testing target time frame,* and proportion of HIV-positive tests among HIV-exposed infants in testing programs for early infant diagnosis of HIV, by country — one Caribbean and six sub-Saharan African countries, 2011–2015

Abbreviations: HIV = human immunodeficiency virus; ND = no data available; PCR = polymerase chain reaction.
* The World Health Organization recommends testing HIV-exposed infants in resource-limited settings using PCR technology at age 4–6 weeks to optimize detection of intrauterine, intrapartum, and early postnatal transmissions.

TABLE 2. Selected site-level* indicators for testing programs for early infant diagnosis of HIV, by country — one Caribbean and six sub-Saharan African countries, 2011–2015

Abbreviations: HIV = human immunodeficiency virus; ND = no data available.
*Site refers to health facility or testing laboratory.
^† Mean turnaround time from blood collection at health facility to laboratory results returned to referring facility.

TABLE 3. Challenges and successes* to access to HIV testing for early infant diagnosis, by country — one Caribbean and six sub-Saharan African countries, 2011–2015

Abbreviations: C = challenge; HIV = human immunodeficiency virus; S = success.
* Challenges and successes were based on country self-report.
^† Country did not report a particular challenge or success.